¿ Acambis plc, of Cambridge, UK, began trading on the Nasdaq Market in the form of American depository receipts under the symbol "ACAM." Each ADR represents 10 ordinary shares of Acambis. The company focuses on infectious disease vaccines.
¿ Access Pharmaceuticals Inc., of Dallas, said preliminary interim data from its Phase II randomized study comparing OraRinse to its mucoadhesive vehicle for the prevention and treatment of mucositis indicated that the interim analysis of 23 evaluable patients did not show a statistically significant difference between the two arms of the study. The study did find, however, that the mucoadhesive vehicle, compared to historical data on mucositis, showed "interesting results." Four of the 11 evaluable patients treated with the mucoadhesive vehicle had only minimal evidence of mucositis at any time during the course of treatment. Access's stock (AMEX:AKC) fell $1.01 Tuesday, or 25 percent, to close at $3.04.
¿ Arena Pharmaceuticals Inc., of San Diego, completed its acquisition of Bunsen Rush Laboratories Inc., of Dallas, for $15 million in an all-cash transaction. Arena announced its intention to purchase the company as a fiscally preferable alternative to licensing Rush's Melanophore Technology, a functional-based screening technology used to identify compounds that interact with cell surface receptors, including known and orphan G protein-coupled receptors and receptor tyrosine kinases. (See BioWorld Today, Dec. 29, 2000.)
¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., said a paper published in the March 1, 2001, issue of Blood reports definitive preclinical studies supporting the use of Argent gene regulation technology for treatment of graft-vs.-host disease. Ariad's regulated cell therapy product based on the Argent gene regulation technology is in Phase II testing.
¿ AtheroGenics Inc., of Atlanta, filed an investigational new drug application with the FDA for AGIX-4207, a novel orally administered treatment for rheumatoid arthritis. The compound is a selective modulator of tumor necrosis factor that blocks a subset of TNF activity.
¿ AxCell Biosciences Inc., of Princeton, N.J., a subsidiary of Cytogen Corp., also of Princeton, said the integration of a Protein-Protein Interaction module developed by Informax Inc., of Rockville, Md., with AxCell's Inter-Functional Proteomic Database will make a broad range of protein-protein interaction information available through Informax's GenoMax bioinformatics system. Informax has exclusive distribution rights to AxCell's Inter-Functional Proteomic Database. The companies expect the product to be available for commercial use in the second quarter.
¿ BioPulse International Inc., of San Diego, promoted Reid Jilek to chairman and CEO. Jilek assumes the role formerly held by Jonathan Neville, who will remain with the company and focus on the development of diagnostic and therapeutic technologies.
¿ Cyclacel Ltd., of Dundee, Scotland, said its lead candidate, CYC202, a cell cycle drug of the cyclin dependent kinase inhibitor class, entered Phase I trials in cancer patients. The trial will evaluate pharmacokinetics and tolerability.
¿ Cytoclonal Pharmaceuticals Inc., of Dallas, said it developed a library of inhibitors that spans at least 8,000 genes, about a quarter of the estimated known human genes. The inhibitor library was created using Cytoclonal's high-throughput Oasis technology, which identifies optimized antisense inhibitors for known genes.
¿ Cytomedix Inc., of Deerfield, Ill., said its treatment for diabetic foot ulcers, which uses the Autologel Process, Cytomedix's proprietary process comprised of naturally occurring growth factors, exhibited a 77.6 percent success rate for total diabetic foot ulcers healed. The company said the Autologel Process will undergo further research on a retrospective and prospective basis.
¿ CytRx Corp., of Atlanta, said it initiated a research program to investigate the use of CRL-5861 (purified poloxamer 188) as an anticancer agent. CytRx said the compound possesses properties that appear to increase the blood flow to poorly perfused areas of tumors, which could allow for more effective chemotherapeutic treatments. It plans to begin further preclinical studies of the compound to evaluate efficacy in combination with chemotherapy. CytRx also said it entered a licensing agreement with Ivy Animal Health Inc., of Overland Park, Kan., providing Ivy with an exclusive worldwide license to CRL-876, CytRx's nonantibiotic feed additive designed to enhance growth performance in monogastric food animals including poultry and swine.
¿ FeRx Inc., of San Diego, initiated a Phase I/II trial investigating its lead product, MTC-DOX, a metastatic liver cancer treatment. The compound is currently in Phase I/II testing in patients with primary liver cancer. The trial is expected to evaluate the compound in 18 to 24 patients with cancers that have metastasized to the liver, including colorectal, pancreatic and breast cancers.
¿ Genelabs Technologies Inc., of Redwood City, Calif., and Watson Pharmaceuticals Inc., of Corona, Calif., said the FDA rescheduled the Mar. 13, 2001, Arthritis Advisory Committee meeting to April 19, 2001. Genelabs' new drug application for Aslera, its chronic autoimmune disease and systemic lupus erythematosus treatment licensed exclusively to Watson, is slated for review at the meeting.
¿ Genomic Solutions Inc., of Ann Arbor, Mich., filed a motion for summary judgement seeking dismissal of the lawsuit filed by PerkinElmer Inc., of Boston, on Feb. 12 in Delaware Chancery Court.
¿ Hemispherx Biopharma Inc., of Philadelphia, initiated HIV salvage treatment trials in the European Union. The Phase II/III protocols testing Ampligen will begin immediately in HIV-infected patients who have exhausted all other treatment options. Ampligen is designed to trigger therapeutic synergism with marketed antivirals, stimulate the immune "memory" cells to potentially cause an attack on HIV cells residing in "sanctuary" regions and minimize toxicity of marketed antivirals.
¿ IGT Pharma Inc., of Vancouver, British Columbia, and NTB Neurotrophic Bioscience Inc., of Toronto, said they closed a transaction creating Prescient NeuroPharma Inc. IGT has assumed that name, and as of Monday began trading on the Canadian Venture Exchange under the symbol "PRE." The combined company now has 26 million shares issued and outstanding, and stock options and warrants entailing another 2 million shares.
¿ KS Biomedix Holding plc, of London, entered a research and development collaboration with Aurelium BioPharma Inc., of Montreal, that calls for KS to develop super-high-affinity antibodies for Aurelium protein targets expressed on tumor cells that are resistant to a wide range of anticancer drugs. The antibodies will be designed to reverse or modify multidrug-resistant tumor cells or to target and destroy those cells. The companies initially will focus on blood cancers.
¿ Lorus Therapeutics Inc., of Toronto, said the FDA granted orphan status for its anticancer agent Virulizin, a prostate cancer therapeutic. Virulizin is a nontoxic immunotherapy that recruits monocytes and macrophages to attack tumor cells. Lorus plans to begin a pivotal Phase III trial in North America later this year.
¿ Lynx Therapeutics Inc., of Hayward Calif., entered several collaborative research agreements with leading researchers. The collaborations will apply Lynx's Megasort technology to uncover differentially expressed genes in several research areas.
¿ MacroChem Corp., of Lexington, Mass., said the February issue of Urology carries a paper detailing a successful Phase II study demonstrating the safety and efficacy of Topiglan, its topical drug for erectile dysfunction. It has filed the results with the FDA and is in a pivotal Phase III trial to support an application for marketing approval. MacroChem's stock (NASDAQ:MCHM) jumped 96.8 cents Tuesday, or about 30 percent, to close at $4.218.
¿ Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., said an article published in Respiratory Research reviews international research conducted by Magainin scientists demonstrating the role of inerleukin-9 as a therapeutic target for asthma. Increased lung IL-9 expression in mice and humans is, the company said, tightly and specifically associated with asthma and its risk factors.
¿ Maxygen Inc., of Redwood City, Calif., formed a three-year collaboration with the International AIDS Vaccine Initiative (IAVI) and DBLV LLC, a formation of the Rockefeller Foundation, to develop an HIV vaccine using Maxygen's MolecularBreeding technology. The aim of the collaboration is a vaccine that has activity against a number of HIV strains. DBLV will provide Maxygen with full research and development funding for at least three years, and Maxygen will retain worldwide commercialization rights. The deal also includes a royalty-free license for the IAVI to develop and distribute the vaccine to those who cannot afford it and in developing countries.
¿ Nobex Corp., of Research Triangle Park, N.C., said studies of its oral insulin candidate have progressed on schedule and produced no safety concerns after dosing in more than 60 diabetic patients in five separate Phase II studies. Nobex presented the clinical progress update at the American Association for the Advancement of Science meeting in San Francisco.
¿ NuOncology Labs Inc., of Virginia Beach, Va., said a study showing the mechanism of action for its lead anticancer compound was published in the January issue of Oncology Reports. The study shows the compound, Arglabin-DMA, inhibits the incorporation of farnesylpyrophosphate into human H-ras protein by the enzyme farnesyl transferase. Mutated ras genes, the company said, produce defective ras proteins that relay uncontrolled proliferative signals.
¿ OraPharma Inc., of Warminster, Pa., said the FDA approved its adjunct treatment for periodontitis following scaling and root planing, Arestin, for marketing. Arestin is the company's first product to reach commercialization. The company expects to launch it in early April. The FDA accepted the company's NDA for Arestin last April. (See BioWorld Today, April 27, 2000.)
¿ Pharming Group N.V., of Leiden, the Netherlands, licensed its small antibacterial peptides technology to AM-Pharma, also of Leiden, for an equity stake in AM-Pharma. Additional financial details were undisclosed. The technology was developed and patent applications filed for the technology in collaboration with the Department of Infectious Diseases at the Leiden University Medical Center. Pharming also said the journal Infection and Immunity published a paper that indicates its recombinant human lactoferrin and peptides derived from the protein's N-terminus are highly effective in animal models against pathogenic bacterial strains, including Staphylococcus aureus.
¿ Protein Design Labs Inc., of Fremont, Calif., began a Phase II trial to evaluate its SMART 1D10 Antibody in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. The multicenter, open-label, two-arm, randomized, 60-patient study is designed to evaluate the compound's safety and efficacy in addition to overall response rate and response duration in two dose levels. Complete and/or partial tumor regression is the primary efficacy endpoint.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., said an article published in the International Journal of Immunopharmacology reports that Zadaxin, its immune system enhancer, is able to potentiate the action of cytokines and reduce the hematological toxicity of cytotoxic drug therapy. Zadaxin, approved in some countries as a treatment for hepatitis B and hepatitis C and as a vaccine adjuvant for patients with weakened immune systems, is currently in Phase II trials as an anticancer therapeutic for treatment of malignant melanoma and hepatocellular carcinoma.
¿ Serono Inc., of Norwell, Mass., initiated a double-blind, placebo-controlled study evaluating Serostim (somatropin, rDNA origin, for injection), a recombinant human growth hormone, as a treatment for HIV-associated adipose redistribution syndrome, a subset of abnormal disorders of fat distribution and altered metabolism also known as HIV-related lipodystrophy syndrome. The study will involve more than 200 patients.
¿ SuperGen Inc., of San Ramon, Calif., said it completed patient enrollment in its Phase III study of rubitecan, an oral chemotherapeutic, in treatment of pancreatic cancer in Gemzar-refractory patients. The study enrolled more than 400 patients, and enrollment for two other Phase III studies of the compound in chemotherapy-naove patients is ongoing. SuperGen said in September it expects to file a new drug application for the compound around the middle of this year, several months later than it initially planned. (See BioWorld Today, Sept. 5, 2000.)
¿ Therion Biologic Corp., of Cambridge, Mass., and the National Cancer Institute initiated a Phase I trial for CEA-Tricom, a novel vaccine that incorporates a triple dose of co-stimulatory molecules as well as the CEA tumor antigen. The compound is designed to strengthen the body's immune system to kill colorectal cancer cells.
¿ United Therapeutics Corp., of Research Triangle Park, N.C., completed enrollment in its Phase III study of oral beraprost in patients with intermittent claudication. The 700-patient, randomized, double-blind, placebo-controlled study is designed to evaluate beraprost's effect on exercise treadmill tests after 24 weeks of treatment, and the company said the trial is expected to yield efficacy results late this year.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., said it will proceed with a Phase I trial of the lead candidate from its sulfonyl hydrazine prodrug family, VNP40101M. The trial is expected to begin in about two months, and will evaluate the compound's safety and maximum tolerated dose in 20 to 30 patients.
¿ YM Biosciences Inc., of Mississauga, Ontario, said it is recommencing Phase II trials of Tesmilifene in patients with hormone-refractory prostate cancer. If the trials confirm data garnered from treatment of 16 patients in a pilot Phase II study that indicated the compound produced a clinical benefit, the company said it anticipates initiating a randomized pivotal study of the compound by the end of the year.